Clinical Effectiveness of the ReHand App in Hand Rehabilitation After Stroke
April 5, 2022 updated by: Pablo Rodríguez, University of Seville
ReHand. The First Tablet Solution for the Neurological Post-Stroke Rehabilitation of the Most Functional Body Segment, The Hand
Stroke is the third leading cause of disability worldwide, with the hand being one of the segments whose affectation generates the greatest limitation in functional ability and quality of life.
Neurorehabilitation is the most effective therapy as long as it is implemented both in the early (post-hospital stages) and in an intensive approach.
However, the resources of healthcare systems are not enough to address the neurorehabilitation needs of patients with hand affectation after stroke.
Thus, current scientific literature advocates transferring such rehabilitation to the patient's home through therapeutic exercise programs - whose clinical and economic effectiveness has already been demonstrated - as a way of reducing the consumption of resources.
In order to achieve this, telerehabilitation is suggested as one of the most viable formats.
However, current telerehabilitation systems such as video games and virtual reality do not provide a fully viable solution, mainly due to the lack of scalability and penetration of the technology, and the lack of a hand specific approach, whose importance is crucial in the recovery of function and autonomy in Activities of Daily Living (ADL).
Different articles and reviews confirm the potential of tablet devices to solve these issues given their scalability and the multisensory feedback provided, making possible a more productive and intensive motor training and sensory stimulation in order to optimize cortical reorganization and neuroplasticity after a stroke.
Both health professionals and patients have expressed the need for a specific Tablet application for neurorehabilitation of the hand after stroke, that follows the precepts established by the evidence.
However, the lack of specific applications for this approach means that existing apps are used as an adaptation.
Therefore, we propose the development and preliminary validation of ReHand, the first Tablet application developed according to the needs of healthcare professionals and patients, and the precepts of the most updated scientific literature, which allows the patient to perform an active therapy adapted to its hand limitations, and the healthcare professional to monitor their patient's home performance.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Older than 18 years.
- From 1 week to 6 months after stroke
- Ischemic or hemorrhagic stroke confirmation by computed tomography or magnetic resonance imaging.
- No previous impairments of the upper limb with the stroke affectation.
- Score above 20 on the Minimental State Examination test.
- Alertness and medical stability declared by the responsible neurologist and with ability to follow simple verbal commands
- Ability to move fingers, even partially.
Exclusion Criteria:
- Acute traumatic or orthopedic involvement of the limb in concern.
- Unstable medical condition (life expectancy less than 3 months, uncontrolled hypertension, unstable angina, recent myocardial infarction, etc.).
- Any medical condition that may confound interpretation of results or put the patient at risk (e.g. amputated finger, psychiatric illness, etc.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tablet Application
An exercise program based on the current evidence will be provided through a tablet application (ReHand) along with the face-to-face conventional approach of each recruitment centres.
A follow-up of the use of the application will be carried out.
The treatment protocol will last 4 weeks, including daily exercise sessions of 30-60 minutes of duration at home though the application tablet.
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Participants will receive a tablet app (ReHand) along with face-to-face physiotherapy sessions.
The ReHand app includes an exercise program based on current scientific evidence for improving funcional ability and dexterity of the hand with neurological affectation.
Those exercises are performed making controlled taps and movements while touching the touchscreen and guided by feedbacks.
Also, ReHand app includes a prescription and monitoring web-based system for professionals.
Along with this intervention, face-to-face physiotherapy sessions will be performed their respective centres.
|
|
Active Comparator: Conventional Treatment
Participants included in this group will receive the conventional treatment protocol usually prescribed on each recruitment centres.
Participants will be asked to perform an exercise program on paper during 4 weeks at home, along with face-to-face sessions.
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Participants of this group will receive a home exercise program on paper and face-to-face physiotherapy sessions.
This intervention is the conventional approach usually delivered in their respective centres.
Those exercises were specifically developed for the rehabilitation of the hand with neurological affectation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)
Time Frame: Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.
|
A specific scale for the assessment of sensorimotor function of the upper limb after stroke.
It includes 33 items, which are rated from 0 to 2 (0 = cannot perform it, 1 = partially perform it, 2 = maximum performance).
Its overall score range from 0 to 66. Higher values correspond to greater motor ability.
|
Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dexterity assessed using the Nine Hole Peg Test
Time Frame: Change from Baseline Nine Hole Peg Test at 4 weeks
|
Plastic instrument with a shallow round dish to contain pegs and nine holes on the opposite side.
It consist of measuring the time spent to place and remove all the pegs from the holes.
|
Change from Baseline Nine Hole Peg Test at 4 weeks
|
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Grip strength assessed using a hydraulic grip dynamometer
Time Frame: Change from Baseline Grip Strength at 4 weeks
|
The Maximum power of the hand muscles used to firmly grasp an object by wrapping the fingers around it, pressing it against the palm, and using the thumb to apply counter-pressure, using a Hydraulic grip dynamometer
|
Change from Baseline Grip Strength at 4 weeks
|
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Pinch strength assessed using a hydraulic pinch dynamometer
Time Frame: Change from Baseline Pinch Strength at 4 weeks
|
The maximun power of the pinch muscles, pressing the tip thumb against the tip index finger, using an Hydraulic pinch dynamometer.
|
Change from Baseline Pinch Strength at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pablo Rodriguez, University of Seville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2022
Primary Completion (Actual)
February 26, 2022
Study Completion (Actual)
March 26, 2022
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
January 10, 2022
First Posted (Actual)
January 24, 2022
Study Record Updates
Last Update Posted (Actual)
April 6, 2022
Last Update Submitted That Met QC Criteria
April 5, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 825003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.